(60 days)
Not Found
No
The device description and performance studies focus on mechanical function and biocompatibility, with no mention of AI or ML.
No
The device facilitates a medical procedure (burying a catheter) but does not directly treat a disease or condition itself.
No
The device is a tunneling tool kit used to create a subcutaneous tunnel for burying a peritoneal dialysis catheter. It is a surgical tool, not a diagnostic one.
No
The device description clearly outlines physical components made of stainless steel, rigid plastic, and titanium, indicating it is a hardware device, not software-only.
Based on the provided information, the Ritus™ tunneling tool kit is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the Ritus™ tunneling tool kit is used to create a tunnel tract through subcutaneous tissue and seal the end of a catheter. This is a surgical/procedural tool used directly on the patient's body, not for analyzing samples taken from the body.
- The device description focuses on mechanical function. The description details how the tunneling device separates tissue and pulls the catheter, and how the plug seals the catheter. These are physical actions, not diagnostic tests performed on biological samples.
- There is no mention of analyzing biological samples. The text does not describe any process of collecting, preparing, or analyzing blood, urine, tissue, or any other bodily fluid or substance.
- The performance studies are related to biocompatibility and mechanical function. The studies mentioned are biocompatibility testing (how the device interacts with the body) and design verification testing (ensuring the device performs as intended mechanically). These are typical tests for surgical or implantable devices, not IVDs.
In summary, the Ritus™ tunneling tool kit is a medical device used in a surgical procedure, not a diagnostic tool used to analyze samples outside of the body.
N/A
Intended Use / Indications for Use
The Ritus™ tunneling tool kit is used to both create a tunnel tract through subcutaneous tissue and seal the end of the catheter. This allows the external portion of the Covidien™ peritoneal dialysis catheter to be temporarily buried in advance of dialysis for patients that are candidates for delayed peritoneal dialysis treatment.
Product codes
FJS
Device Description
The Ritus™ tunneling tool kit comes with a separate tunneling device and plug. This kit is designed to create a subcutaneous tunnel to temporarily bury the external portion of the peritoneal dialysis catheter within the abdominal, subcutaneous tissue in advance of needing dialysis.
The tunneling device is made of stainless steel with a rigid plastic handle on the proximal end. There is an angled tip with a removable plastic cap. Functioning as a dilator, the tunneling device separates the tissue to create a tunnel tract, then is used to pull the catheter through the tunnel to desired exit site.
The titanium catheter plug is designed to seal the end of the catheter for the length of time that the catheter is buried within the subcutaneous tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue, abdominal, subcutaneous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Materials / Biocompatibility:
Biocompatibility testing was conducted based on the requirements of ISO 10993-1:2018 and using Good Laboratory Practice (GLP). The results of the biocompatibility tests conducted show the Ritus™ Peritoneal Dialysis Catheter Tunneling Tool Kit meets the ISO 10993 requirements and have been deemed acceptable.
Performance Testing:
Design verification testing was performed with the proposed device and is summarized in order to establish the equivalent performance with the predicate. All performance testing met acceptance criteria and supports the determination of substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 14, 2022
Covidien, Ilc Carol Ming Pr. Regulatory Affairs Specialist 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K213602
Trade/Device Name: Ritus™ Peritoneal Dialysis Catheter Tunneling Tool Kit Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FJS Dated: November 11, 2021 Received: November 15, 2021
Dear Carol Ming:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Glenn B. Bell, Ph.D. Director THT3A1: Renal, Gastrointestinal, Obesity and Transplantation Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213602
Device Name
Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
Indications for Use (Describe)
The Ritus™ tunneling tool kit is used to both create a tunnel tract through subcutaneous tissue and seal the end of the catheter. This allows the external portion of the Covidien™ peritoneal dialysis catheter to be temporarily buried in advance of dialysis for patients that are candidates for delayed peritoneal dialysis treatment.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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ട. 510(k) Summary
Medtronic
5.1 Submitter
| Covidien, llc
15 Hampshire Street
| Mansfield, MA 02048 | |
|---|---|
| Contact Person: | Carol Ming |
| Pr. Regulatory Affairs Specialist | |
| Phone: 508.452.1443 | |
| Email: carol.s.ming@medtronic.com | |
| Date Prepared: | November 11, 2021 |
Device Names and Classifications: 5.2
| Trade Name: | Ritus™ Peritoneal Dialysis Catheter Tunneling Tool Kit |
|---|---|
| Common Name: | Peritoneal Dialysis Accessories |
| Regulation Number: | 21 CFR 876.5630 |
| Product Code: | FJS |
| Classification: | Class II |
Predicate Device 5.3
Embedding® Tool, FJS, K060897
Device Description 5.4
The Ritus™ tunneling tool kit comes with a separate tunneling device and plug. This kit is designed to create a subcutaneous tunnel to temporarily bury the external portion of the peritoneal dialysis catheter within the abdominal, subcutaneous tissue in advance of needing dialysis.
The tunneling device is made of stainless steel with a rigid plastic handle on the proximal end. There is an angled tip with a removable plastic cap. Functioning as a dilator, the tunneling device separates the tissue to create a tunnel tract, then is used to pull the catheter through the tunnel to desired exit site.
The titanium catheter plug is designed to seal the end of the catheter for the length of time that the catheter is buried within the subcutaneous tissue.
4
5.5 Indications for Use
| Model Names/Types | Indications |
|---|---|
| RitusTM Peritoneal Dialysis Catheter | |
| Tunneling Tool Kit | The RitusTM tunneling tool kit is used to both create |
| a tunnel tract through subcutaneous tissue and seal | |
| the end of the catheter. This allows the external | |
| portion of the CovidienTM peritoneal dialysis | |
| catheter to be temporarily buried in advance of | |
| dialysis for patients that are candidates for delayed | |
| peritoneal dialysis treatment. |
5.6 Comparison to Predicate Device
The technological characteristics, design and performance of the Tunneling Tool Kit are consistent with those of the predicate devices.
- Intended Use: The intended use of the proposed device and the predicate device is the ● same.
- Materials: Both the proposed device and the predicate device have titanium catheter plugs. The tunneling device for the Tunneling Tool Kit has a similar design as the predicate, but the proposed tunneling device's tip and shaft is made of stainless steel while the predicate is made of rigid polyvinyl compound (RPVC).
- . Principles of Operation and Technology: The technology of the proposed device and the predicate device is the same.
- Performance: The performance of the proposed device and the predicate device is the same.
5.7 Performance Data
Materials / Biocompatibility:
Biocompatibility testing was conducted based on the requirements of ISO 10993-1:2018 and using Good Laboratory Practice (GLP). The results of the biocompatibility tests conducted show the Ritus™ Peritoneal Dialysis Catheter Tunneling Tool Kit meets the ISO 10993 requirements and have been deemed acceptable.
Performance Testing:
Design verification testing was performed with the proposed device and is summarized in order to establish the equivalent performance with the predicate. All performance testing met acceptance criteria and supports the determination of substantial equivalence to the predicate devices.
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5.8 Conclusions
The indications for use and intended use of the Ritus™ Peritoneal Catheter Tunneling Tool Kit is substantially equivalent to that of the predicate device. Additionally, Covidien has demonstrated that the device works as designed and intended.